Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150015—Source of blood
  • A61B5/15003—Source of blood for venous or arterial blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
  • A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
  • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
  • A61B5/150297—Manufacture or production processes or steps for blood sampling devices for piercing devices, i.e. devices ready to be used for lancing or piercing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150381—Design of piercing elements
  • A61B5/150473—Double-ended needles, e.g. used with pre-evacuated sampling tubes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
  • A61B5/150641—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
  • A61B5/150648—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position fully automatically triggered, i.e. the triggering of the protective sleeve does not require a deliberate action by the user such as terminating the contact with the patient's skin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150694—Procedure for removing protection means at the time of piercing
  • A61B5/150702—Procedure for removing protection means at the time of piercing fully automatically removed, i.e. the removing does not require any action by the user
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
  • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
  • A61B5/150694—Procedure for removing protection means at the time of piercing
  • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/150007—Details
  • A61B5/150732—Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/15—Devices for taking samples of blood
  • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
  • A61B5/154—Devices using pre-evacuated means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
  • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
  • A61M5/321—Means for protection against accidental injuries by used needles
  • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel

Definitions

• the present invention pertains generally to fluid collection systems. More particularly, the present invention pertains to fluid aspiration systems that are useful for collecting blood.
• the present invention is particularly, but not exclusively, useful as a blood collection system having an automatically activated guard that covers the needle to protect users from accidental "sticks" after blood has been collected.
• an object of the present invention to provide a safety system for a blood collection device that has an automatic, ready-to- activate, needle guard for covering and protecting the needle after its use.
• Another object of the present invention is to provide a safety system for a blood collection device that automatically locks the needle guard in place after the needle has been used.
• Yet another object of the present invention is to provide a safety system for a blood collection device that is simple to manufacture, is easy to use and is comparatively cost effective.
• a safety system for a blood collection device includes a tubular shaped holder and a tubular shaped guard.
• the holder and guard then interact with each other to protect the needle of the device after it has been used.
• the holder defines a longitudinal axis, and it has an inner surface that surrounds a lumen.
• a distal abutment and a proximal abutment are formed on the inner surface of the holder, along with a plurality of longitudinally oriented ribs. More specifically, the ribs individually extend from the inner surface of the holder and each rib is formed with a detent.
• the needle is mounted on an adapter, and the adapter is affixed to the ribs by a snap engagement with the respective detents. This aligns the needle along the axis of the holder.
• the guard is positioned inside the lumen of the holder with its outer surface facing the inner surface of the holder.
• a spring is positioned between the guard and the adapter to urge the guard in a distal direction along the axis.
• the guard is formed with a cantilevered tab that can be outwardly deflected from the surface of the guard, into a stressed configuration.
• the spring urges the tab against the distal abutment on the holder to prevent further movement of the guard in a distal direction. This puts the guard in a ready-to-activate condition.
• the tab when the tab is lifted from the distal abutment it will move from its stressed configuration, into an unstressed configuration. In this unstressed configuration, the cantilevered tab is flush with the outer surface of the guard and is clear of any interaction with the holder.
• the guard is sequentially moved through three, distinctly identifiable positions. These are an initial position, a retracted position, and a final (locked) position. In its initial position (i.e.
• the cantilevered tab on the guard is in its stressed configuration. Also, the tab is being urged against the distal abutment to hold the guard stationary, relative to the holder. In this initial position, a distal portion of the needle extends from the guard. A cover can be engaged with the holder to protect the exposed distal end of the needle. For use of the system in a blood collection procedure, the cover is removed from the holder. The needle is then inserted to establish fluid communication with a patient (fluid source). With this insertion, the guard is moved over the needle in the proximal direction to the retracted position. This causes further exposure of the needle and causes the cantilevered tab to be lifted from the distal abutment.
• the cantilevered tab then transitions into its unstressed configuration.
• the needle is withdrawn and the guard moves in the distal direction to its final position.
• the guard covers the distal portion of the needle, and an extension limiter that is formed on the guard is engaged with the proximal abutment to prevent an uncovering of the distal portion of the needle.
• Fig. 1 is a perspective view of the safety system for a fluid collection device in accordance with the present invention
• Fig. 2 is an exploded view of the system showing the interrelationship of its constituent components
• Fig. 3 is a perspective view of the holder
• Fig. 4 is a cross-sectional view of the holder as seen along the line 4-4 in Fig. 3
• Fig. 5 is a perspective view of the guard
• Fig. 6 is an end view of the guard as seen along the line 6-6 in Fig. 5;
• Fig. 1 is a perspective view of the safety system for a fluid collection device in accordance with the present invention
• Fig. 2 is an exploded view of the system showing the interrelationship of its constituent components
• Fig. 3 is a perspective view of the holder
• Fig. 4 is a cross-sectional view of the holder as seen along the line 4-4 in Fig. 3
• Fig. 5 is a perspective view of the guard
• Fig. 6 is an
• Fig. 8A is a cross-sectional view of the system as seen along the line 8-8 in Fig. 1 with the guard in its initial position
• Fig. 8B is a cross-sectional view of the system as seen along the line 8-8 in Fig. 1 with the guard in its retracted position
• Fig. 8C is a cross-sectional view of the system as seen along the line 8-8 in Fig. 1 with the guard in its final, locked position.
• a safety system for a blood collection device is shown and generally designated 10.
• the system 10 includes a holder 12 and a cover 14 that is engageable with the holder 12.
• all of the various components of the system 10, and their interrelationship with each other are, perhaps, best seen with reference to Fig. 2.
• the system 10 is shown to include a guard 16, a spring 18, a needle 20, and an adapter 22, as well as a sheath 24. These components are shown aligned along an axis 26, with the cover 14 being shown in a distal position, and the sheath 24 being shown in a proximal position. Details of the holder 12 will be best appreciated with reference to both Fig.
• Fig. 3 shows that the holder 12 is externally formed with finger grips 28 (the grips 28a and 28b are exemplary), and a base flange 30.
• Fig. 4 shows that the holder 12 is substantially tubular in shape and that, internally, it has an inner surface 32 that surrounds a lumen 34. Further, it is seen that the inner surface 32 is formed with a distal abutment 36, and at least one proximal abutment 38. Still further, it is seen that the inner surface 32 of holder 12 is formed with ribs 40 (the ribs 40a and 40b are exemplary) that extend longitudinally in the lumen 34 of holder 12, substantially parallel to the axis 26.
• ribs 40 e.g. ribs 40a and 40b
• detents 42a and 42b are shown formed with a respective detent 42 (e.g. detents 42a and 42b).
• the guard 16 is best understood with reference to both Fig. 5 and Fig. 6. Specifically, Fig. 5 shows that the guard 16 is formed with a cantilevered tab 44 and a pair of extension limiters 46a and 46b (also see Fig. 6). More specifically, the cantilevered tab 44 is shown flush with the outer surface 48 of the guard 16 in Fig. 5. In this configuration (i.e. when the tab 44 is flush with the outer surface 48) the cantilevered tab 44 is unstressed.
• Fig. 5 also shows the cantilevered tab 44 is formed with a channel 50. Specifically, the channel 50 is provided so that a tool (not shown) can be inserted into the channel 50 from the proximal end of the guard 16 to deflect the cantilevered tab 44 into its stressed configuration during assembly of the system 10. Additionally, Fig. 6 shows that the guard 16 is formed with a pair of ridges 52a and 52b that form a groove 54. Fig.
• the adapter 22 includes an extension 56 that is formed with a shoulder 58.
• This extension 56 of adapter 22 is formed with a lumen 60 and, additionally, the adapter 22 includes a disk 62 that is oriented substantially perpendicular to the extension 56. Further, the adapter 22 has a pair of parallel prongs 64a and 64b that are substantially perpendicular to the extension 56.
• the needle 20 is positioned through the lumen 60 of adapter 22 and is held on the adapter 22 by means well known in the pertinent art, such as by solvent bonding.
• the spring 18 is then placed over the distal end (portion) 68 of the needle 20, and also over the extension 56 of the adapter 22.
• the guard 16 is positioned so that one of the ribs 40 (e.g. rib 40b) is received in the groove 54 created by the ridges 52a and 52b. This interaction then prevents a rotation of the guard 16 relative to the holder 12. Also, during this insertion, the prongs 64a and 64b on adapter 22 are positioned to also straddle one of the ribs 40. With these components oriented in this manner, insertion continues until the disk 62 of adapter 22 snaps into engagement with the detents 42 of ribs 40. With the snap engagement of adapter 22 with the detents 42 on ribs
• the cantilevered tab 44 (now in its stressed configuration) is forced by the compressed spring 18 into contact with the distal abutment 36. Specifically, as long as there is no proximally directed force on the guard 16, the distally directed force of spring 18 will hold the cantilevered tab 44 against the distal abutment 36, in its stressed configuration.
• the cover 14 is then engaged with the holder 12 to protect the otherwise exposed distal end (portion) 68 of the needle 20. This places the guard 16 in an initial position where it is in a ready-to-activate condition (see Fig. 8A). In the operation of the system 10 of the present invention, the cover 14 is first removed. As seen in Fig.
• a fluid collection vial (not shown) can be connected in fluid communication with the proximal end 76 of needle 20. As will be appreciated by the skilled artisan, sequential fluid collection vials can be so connected. Then, after the fluid collection procedure is completed, the needle 20 can be withdrawn from the patient. With this withdrawal, the compression force in spring 18 causes the guard 16 to move in a distal direction along the axis 26 to move the guard 16 into its final (locked) position (Fig. 8C). In this final position, the ridges 52a and 52b on guard 16 are in contact with the holder 12 to prevent any additional movement of the guard 16 in a distal direction on the holder 12.
• the extension limiters 46a and 46b on the guard 16 are engaged, respectively, with a proximal abutment 38 to prevent any additional movement of the guard 16 in a proximal direction on the holder 12.
• the guard 16 is locked to cover the distal end (portion) 68 of needle 20 to protect the user from an inadvertent "stick" by the needle 20.
• the system 10 can then be discarded.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Heart & Thoracic Surgery (AREA)
• Molecular Biology (AREA)
• Pathology (AREA)
• Physics & Mathematics (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Medical Informatics (AREA)
• Biophysics (AREA)
• Surgery (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Manufacturing & Machinery (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

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Related Child Applications (1)

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• 2003
  • 2003-07-17 US US10/621,973 patent/US7357783B2/en not_active Expired - Fee Related
• 2004
  • 2004-07-15 EP EP04757044A patent/EP1646421B1/fr not_active Expired - Lifetime
  • 2004-07-15 JP JP2006520351A patent/JP4699996B2/ja not_active Expired - Fee Related
  • 2004-07-15 CN CNB2004800241093A patent/CN100542625C/zh not_active Expired - Fee Related
  • 2004-07-15 CA CA002532915A patent/CA2532915A1/fr not_active Abandoned
  • 2004-07-15 AT AT04757044T patent/ATE533528T1/de active
  • 2004-07-15 EP EP10191849A patent/EP2281599A3/fr not_active Withdrawn
  • 2004-07-15 WO PCT/US2004/022828 patent/WO2005009507A2/fr not_active Ceased

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